The authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the documents contained in the registration dossier for already medicinal product. Recommended by the authors of the sequence of procedures for determining the interchangeability of drugs includes four successive stages. The conformity assessment of generic medicinal product reference drug proposed by six parameters specified in the Federal Law N 429-FZ, in sequence («Аlgorithm for the assessment of interchangeability»).

Drug stress studies are conducted in order to identify drug degradation products under the influence of stress conditions. The principles of stress studies depend on characteristics of an active substance. The following factors accelerating chemical reactions are being used: temperature, light, moisture, pH, oxygen, carbon dioxide. The obtained results are required for the development of impurity identification and assay methods as well as for the choice of appropriate conditions for drug manufacture and storage.

Method of X-ray phase analysis based on obtaining and analyzing the diffraction pattern resulting from the diffraction of x-rays scattered by electrons of the atoms of the irradiated polycrystalline sample. Using this method in the framework of a pre-registration examination the study of pharmaceutical substances temosolomide, form I of valacyclovir hydrochloride monohydrate and quetiapine fumarate (form I) to confirm their authenticity. The results obtained allowed to conclude that the claimant substance temosolomide is not primary, and the substance of valacyclovir does not meet the stated requirements in terms of "Authenticity".

The present article describes the analysis of the results of pharmaceutical expert evaluation of propolis preparations, performed in the laboratory of microbiology of the FSBI «SCEMP» of the Ministry of Health of the Russian Federation for the period of 2006-2014 in terms of «Antimicrobial activity». During the mention period 43 batches of medicinal products were analyzed, a significant part o which were solid domestic drugs (93%). Experimentally determined the effect of individual factors, such as the type of microorganism, the concentration and choice of nutrient medium, on the result of the analysis for this terms.

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Brief description of the opportunities and benefits of applying the methodology of clinical pharmacology and personalized medicine, pharmacokinetics, and pharmacodynamics of medicines, as well as the possibilities of evaluation of metabolic biotransformation and drug interactions to improve the efficacy, safety, therapeutic and pharmacodynamic effects of medicines, is given. These features and techniques should be extensively used for expert evaluation of efficacy and safety of drugs. The introduction of modern methods of diagnostics and treatment in clinical practice will require building a system that could be implemented in the Centres of personalized medicine.

The review describes the new chirally pure drug - levosalbutamol for the treatment of bronchial asthma. It summarizes historical information about the development of the product, data on its pharmacological properties and the results of clinical trials conducted in healthy volunteers and in patients. The presented data allow to draw conclusions on the drug pharmacokinetic properties, its efficacy and safety in patients suffering from bronchial asthma.

Brief information about the program of the World Health Organization (WHO) for International Nonproprietary Names (INN) for drugs and the role of the INN in the sphere of circulation of medicines is represented. The general principles of INN selection and requirements for development applications for the INN are described. The assignment of an INN of the pharmaceutical substance is the highest criterion for recognition by the international expert community of innovative medicines created by a particular developer and makes it possible to objectively judge the contribution of different countries in global health. Questions of functioning of the national system of the selection and introduction of INN for domestic original pharmaceutical medicines have the high urgency.

The analysis of the international experience in conducting preclinical studies and application of the principle of good laboratory practice was made. The issues associated with the use of laboratory animals for scientific purposes in Russia and abroad were discussed. The prospects of improvement of legislative base of the Russian Federation in the field of preclinical studies with the application of the principle of good laboratory practice and use of laboratory animals for scientific purposes were identified.

Many recent studies have confirmed the effect of NO and that its relative signaling pathway is important for preconditioning of the cardioprotective effect. Mitochondria as a target for the cardioprotective effects of nitric oxide in ischemia-reperfusion injury is considered to be the ultimate goal of cardioprotection. During preconditioning, signaling is initiated from the sarcolemmal membrane and then spread into the cytoplasm via many series of enzymes, including nitric oxide synthase (NOS), soluble guanylyl cyclase (sGC), and protein kinase G (PKG). As a result, the signal is transmitted into the mitochondria, where the cardioprotective effect occurs. It is now well established that mitochondria act to protect the heart against ischemia-reperfusion injury via the opening of the mitochondrial ATP-sensitive K+ channel and the inhibition of mitochondrial permeability transition. This knowledge may be useful in developing novel strategies for clinical cardioprotection from ischemia-reperfusion injury.

The article describes common principles for the validation of computer information systems and personal computers used as a basis for pharmaceutical information systems. The principles are elaborated in accordance with OMCL Network international requirements and international ISO standards. The article also provides classification used for information systems in pharmaceutical organizations. It describes common concepts for the validation of information systems: version management, validation testing, change management, requirements traceability. Common requirements for the use of risk management system for the purpose of development are also provided.

This article provides the analysis of the updated versions of the existing legislative framework, regulating legal relations in the state registration of intellectual property. It considers expert views on the mentioned issue and provides with certain recommendations that are reasonable to be taken into account when patenting inventions in the Russian Federation. The authors analyzed the foreign law enforcement protection of intellectual property in the pharmaceutical sphere. The information described in the present article may be useful for experts involved in registration and introduction of scientific results when preparing and maintaining the documentation required for an application for state registration of intellectual property, including the pharmaceutical sphere.

The State Pharmacopoeia of the Russian Federation is a collection of general monographs and pharmacopoeial monographs. It should be reissued at least once in 5 years. The next scheduled edition of the State Pharmacopoeia of the Russian Federation is planned for publication in 2015. It will include both first developed in national and, in some cases, global pharmacopoeial analysis general and pharmacopoeial monographs, and updated revised general and pharmacopoeial monographs. The implementation of the general and pharmacopoeial monographs of the mentioned edition of the State Pharmacopoeia of the Russian Federation will significantly increase the level of national pharmacopoeial analysis and ensure its compliance with international standards.

Pharmacoeconomic analysis includes the assessment of direct cost structure in pharmacotherapy of cerebral infarction for the period of 2009-2011 in healthcare institutions in Saratov (762 patients) based on ABC analysis and frequency analysis. The results of the mentioned analysis showed the presence of drugs without proven efficacy and a very high associated cost component (75.67%) of purchasing budget in drug group «A». It was revealed, that the drugs of scientifically substantiated efficacy and safety are not used sufficiently in treatment of cerebral infarction. On the other hand the drugs without proven efficacy are widely used, which leads to an increase in financial losses of the state and population. The results of clinical and economic analysis showed the need for changing the cost structure for drug therapy of the mentioned disease in hospitals.